Home Visit app to optimize virtual clinical trials

07 May 2020

Cmed Technology announced today the encapsia Home Visit app is now available to capture and manage clinical trial data from patients at home or in the community. The app works seamlessly with all the other encapsia apps, including web EDC (Entry app) and direct data capture (esource app) to provide tremendous flexibility in the choice of data capture methods both before and during a study. This helps maintain patient participation and clinical data flow which is particularly compelling to minimize disruption during the COVID-19 pandemic as well as in the new landscape for clinical trials that is expected to follow.

Support for Virtual Clinical Trials from Cmed

30 Apr 2020

The dramatic coronavirus (COVID-19) pandemic has disrupted all aspects of daily life including clinical trials. Medical staff limitations and reorganizations, travel bans and access restrictions to medical facilities have challenged sponsors and sites’ current clinical trial processes.
The coronavirus outbreak has effectively forced a change in patient care and clinical trials. To continue bringing new therapies to market and support patients, sites and sponsors have accelerated the adoption of new technologies into decentralized trials or hybrid trials.

A message for our clients, investigator sites and industry partners

06 Apr 2020

The global COVID-19 crisis has fundamentally impacted the way we live our lives as well as the operation of the entire drug development community. During the early stages of the pandemic the Cmed leadership team has implemented a number of measures to ensure the safety of our employees, clients and partners, as well as ensuring the continued delivery of our CRO services and our encapsia clinical data system. Our goal has been to minimise the impact of COVID-19 on our business, our clients, investigator sites and patients.

Real World Data Studies

Data management skills and technologies for Real World Studies with Cmed

There is an increasing drive and focus on the collection and use of Real World Data (RWD) within pharmaceutical research and development. With advances in technology and the advent of personalised medicine, the demand for real world data to support the drug development lifecycle continues to gain momentum as well as support from regulatory agencies.

Advances in technology and the advent of personalised medicine have made it feasible to collect more detailed data, from more subjects, more frequently and in real world settings. This extends to the possibility that a subject may not even need to visit the Investigational Site in person. With more detailed data, available more quickly, sponsors can maximise efficiency and speed their decision making throughout the drug development life cycle.

Cmed supports such real world studies and helps to connect sponsors working on new therapies with the patients who benefit from them. By collecting, analyzing and interpreting the data you need, we can bridge the knowledge gap between clinical trials and clinical practice.

Here’s how Cmed can help your Real World study:

Proven scalability and management of large data volumes

EMRs, imaging data, biomarkers, lab data, wearable sensors, data from pharmacy, registries, even social media provide large new sources of real world data that, when properly managed, assimilated and analysed, can shed more light on the use and safety of new therapies as well as treatment patterns and disease progression.

Cmed routinely works on Real World studies with large data volumes or data collection from many data sources:

Our team of Real World Data Specialists

Strategically located around the globe, our Real World specialists work to successfully design and execute studies of any size or objective. Our fit-for-purpose operational approach delivers high quality results with every project.

Focus on Data Quality

Credible real world evidence is only generated from high quality data that is obtained from relevant real world data sources, that is harmonized and includes endpoints.

Quality data must be traceable/auditable, complete, transparent, generalizable, timely, and scalable.
Cmed will work to develop such standards in close collaboration with biopharmaceutical companies and Real World data providers.

Training sessions on processes organised for local data coordinators, data managers and data custodians as applicable.

Automated data quality checks and visual prompts in place at data entry to prevent introduction of erroneous or inconsistent data .

Standard data quality control reports produced at local level to check for missing, unusual or incorrect data; source data verification through manual checks of medical charts or records to be performed secondarily.

Indicators of data quality are measured periodically

encapsia - Technology designed and built for the real world

Encapsia is Cmed’s proprietary EDC system to collect, analyze and manage clinical trial data. Encapsia addresses the limitations of other systems with Real World Data collection including:

Data collected, uploaded or fed into encapsia by integrations can be explored and analyzed in real time with inbuilt visualizations and insights

Encapsia is built to make use of modern architectures and cloud hosting to provide for easy scaling and handling of large data volumes

Encapsia supports mid-study design changes with no downtime for end users

Encapsia has AI compatibility to support rapid and high volume analysis of data

Remote Monitoring

RWD studies typically have infrequent on-site monitoring since there is no IP involved and data is collected as part of routine practice.

This is where Cmed’s Data Management and Analytics teams take a lead role in defining metric reports to monitor performance and progress at site level. Encapsia has remote monitoring capabilities and is able to trigger, target and track data monitoring and review to optimize use of site visits.
Go to Monitoring Models page.